Biomarkers for Prediction of OA Treatment Efficacy, CPAP, Obstructive Sleep Apnea (OSA)
Conditions
Keywords
Obstructive sleep apnea, Sleep apnea syndrome, Continuous positive airway pressure, cpap adherence, Hypoxic burden, Pulse wave amplitude drop index, pwad, Heart rate response, Sympathetic nervous system
Brief summary
Obstructive sleep apnea (OSA) is commonly assessed using the apnea-hypopnea index, although this measure does not fully reflect cardiovascular risk or the physiological impact of the disease. Emerging biomarkers, including sleep apnea-specific hypoxic burden, pulse wave amplitude drop index, and heart rate response, may provide additional information on cardiovascular vulnerability. This prospective multicenter observational study will investigate the association between these biomarkers, measured from the diagnostic sleep study, and adherence to continuous positive airway pressure (CPAP) therapy after three months. Symptoms, quality of life, clinical characteristics, and changes in biomarkers under continuous positive airway pressure will also be evaluated.
Detailed description
This is a prospective, longitudinal, multicenter observational cohort study involving adults with newly diagnosed obstructive sleep apnea for whom continuous positive airway pressure therapy is indicated as part of routine clinical care. At baseline, demographic and clinical characteristics, medical history, current treatments, symptom questionnaires, and results from diagnostic respiratory polygraphy or polysomnography will be collected. Hypoxic burden, pulse wave amplitude drop index, and heart rate response will be calculated from the initial sleep recording. Continuous positive airway pressure will be prescribed according to standard clinical practice. At 12 weeks, with a permitted window of plus or minus four weeks, adherence data will be obtained from the continuous positive airway pressure device. Clinical information and questionnaires will be collected again. Participants requiring a follow-up sleep study as part of routine care may undergo respiratory polygraphy or polysomnography while receiving continuous positive airway pressure, allowing assessment of biomarker changes under treatment. The principal analysis will examine associations between baseline biomarkers and continuous positive airway pressure adherence. Secondary analyses will assess biomarker distributions according to clinical characteristics, associations with symptoms and quality of life, and changes in biomarkers during treatment.
Interventions
DEVICEContinuous Positive Airway Pressure
Continuous positive airway pressure prescribed as part of routine clinical care according to applicable clinical recommendations. The study does not assign the treatment or its settings.
Sponsors
Clinique du Millenaire
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed obstructive sleep apnea with an indication for continuous positive airway pressure therapy * Age older than 18 years * Written informed consent obtained
Exclusion criteria
* Continuous positive airway pressure treatment during the preceding 3 months * Medical contraindication to continuous positive airway pressure therapy * Concomitant condition likely to affect adherence to continuous positive airway pressure, including severe cognitive impairment or an unstable psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association Between Baseline Hypoxic Burden and CPAP Adherence at 3 Months | Baseline to 3 months after CPAP initiation | Association between hypoxic burden measured during the baseline diagnostic sleep study and mean nightly CPAP use during the 30 days preceding the 3-month visit. CPAP adherence will also be categorized as less than 4 hours per night versus 4 hours or more per night. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Baseline Sleep Apnea Biomarkers | BASELINE | Distribution of hypoxic burden, pulse wave amplitude drop index, and heart rate response measured or calculated from the baseline respiratory polygraphy or polysomnography. Results will be described according to sex, age, body mass index, medical history, cardiovascular history, and current treatments. |
| Association Between Baseline Heart Rate Response and CPAP Adherence at 3 Months | Baseline to 3 months after CPAP initiation | Association between the heart rate response to respiratory events (delta heart rate) measured during the baseline diagnostic sleep study and mean nightly CPAP use during the 30 days preceding the 3-month visit. CPAP adherence will also be categorized as less than 4 hours per night versus 4 hours or more per night. |
| Association Between Baseline Pulse Wave Amplitude Drop Index and CPAP Adherence at 3 Months | Baseline to 3 months after CPAP initiation | Association between the pulse wave amplitude drop index (PWAD index) measured during the baseline diagnostic sleep study and mean nightly CPAP use during the 30 days preceding the 3-month visit. CPAP adherence will also be categorized as less than 4 hours per night versus 4 hours or more per night. |
| Daytime Sleepiness Assessed by the Epworth Sleepiness Scale | Baseline and 3 months | Daytime sleepiness will be assessed using the Epworth Sleepiness Scale at baseline and 3 months after CPAP initiation. The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness and therefore a worse outcome. The change in total score between baseline and 3 months will be evaluated. |
| Health-Related Quality of Life Assessed Using the EuroQol 5-Dimension 5-Level Questionnaire | baseline and 3 months | Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at baseline and 3 months after CPAP initiation. The EQ-5D-5L evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, ranging from 1 (no problems) to 5 (extreme problems or inability to perform the activity). Responses will be converted into an EQ-5D-5L utility index using the French value set. Index values range from -0.525 to 1, with higher values indicating better health-related quality of life. The change in the utility index between baseline and 3 months will be evaluated. |
| Change in Sleep Apnea-Specific Hypoxic Burden During CPAP Therapy | baseline and 3 months | Sleep apnea-specific hypoxic burden will be calculated from the oxygen desaturation area associated with respiratory events and expressed as percent-minutes per hour (%min/h). The change from the baseline diagnostic sleep study to the sleep study performed during CPAP therapy at 3 months will be evaluated. Higher values indicate a greater hypoxic burden and therefore a worse outcome. This assessment will be performed only in participants undergoing a follow-up sleep study as part of routine care. |
| Change in Pulse Wave Amplitude Drop Index During CPAP Therapy | Baseline and 3 months after CPAP initiation | The pulse wave amplitude drop index will be calculated as the number of pulse wave amplitude drops per hour of sleep or recording. The change from the baseline diagnostic sleep study to the sleep study performed during CPAP therapy at 3 months will be evaluated. Higher values indicate more frequent pulse wave amplitude drops. This assessment will be performed only in participants undergoing a follow-up sleep study as part of routine care. |
| Goal Attainment Assessed by Goal Attainment Scaling | baseline and 3 months | Goal Attainment Scaling score and its change between baseline and the 3-month follow-up visit. Attainment of the participant's individualized treatment goal will be assessed at 3 months using Goal Attainment Scaling (GAS). Goal attainment is rated on a five-point scale ranging from -2 to +2: -2 indicates a much worse outcome than expected, -1 a somewhat worse outcome than expected, 0 the expected level of goal attainment, +1 a somewhat better outcome than expected, and +2 a much better outcome than expected. Higher scores indicate better goal attainment and therefore a better outcome |
| Change in Heart Rate Response to Respiratory Events During CPAP Therapy | Baseline and 3 months after CPAP initiation | Heart rate response will be measured as the mean change in heart rate associated with respiratory events (delta heart rate). The change from the baseline diagnostic sleep study to the sleep study performed during CPAP therapy at 3 months will be evaluated. Higher values indicate a greater heart rate response to respiratory events. This assessment will be performed only in participants undergoing a follow-up sleep study as part of routine care. |
Countries
France
Contacts
CONTACTFrancois FB Bughin, MD, PhD
Outcome results
None listed